(253 days)
The Definitive, Flexlens, sphere (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes. The lens may be worn by persons who exhibit refractive astigmatism of .75 diopters or less where the astigmatism does not interfere with visual acuity.
The Definitive, Flexlens, toric (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes and/or possesses refractive astigmatism not exceeding 12 diopters.
The Definitive, Flexlens, multifocal (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eves and/or possesses refractive astigmatism not exceeding . 75 diopters and are presbyopic requiring add power of up to +4.00 diopters.
The Definitive, Flextens, multifocal toric (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes and/or possesses refractive astigmatism not exceeding 4 diopters and are presbyopic requiring add power of up to +4.00 diopters.
The Definitive, Flexlens, irregular cornea (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons and may be prescribed in otherwise non-diseased eyes that require a Soft Contact Lens for the management of irregular corneal conditions such as keratoconus and post graft fitting
Eyecare practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be cleaned and disinfected using a chemical (not heat) lens care system or hydrogen peroxide disinfection systems.
The Definitive, Flexlens Silicone Hydrogel Soft Contact Lenses are fabricated from efrofilcon A. which in the dry (unhydrated) state may be machined and polished. The hydrophilic nature of this material allows the lens to become soft and pliable when immersed in an aqueous solution.
The non-ionic lens material, (efrofilcon A) is a daily wear silicone hydrogel contact lens that is not surface treated and characterized by a high water content. The lens material is composed of silicone monomers cross linked with other monomers and optionally incorporates D&C Green 6 as an integrated handling tint. The lenses are made by lathe-cut for custom RX. It consists of 26% efrofilcon A and 74% water by weight when immersed in a buffered saline solution. The (efrofilcon A) name has been adopted by the United States Adopted Names Council (USAN).
In the hydrated state, the lens conforms to the curvature of the eye covering the cornea and extending slightly beyond the limbus forming a colorless, transparent optical surface. The (efrofilcon A) soft hydrophilic contact lens has a spherical back surface. The hydrophilic properties of the lens require that it be maintained in a fully hydrated state in a solution compatible with the eye. If the lens dries out, it will become hard appear somewhat warped however, it will return to its proper configuration when completely rehydrated in the proper storage solution.
Acceptance Criteria and Study Findings for Definitive, Flexlens - Silicone Hydrogel Daily Wear Soft Contact Lens (efrofilcon A)
This document describes the acceptance criteria and the study that demonstrated the Definitive, Flexlens - Silicone Hydrogel Daily Wear Soft Contact Lens (efrofilcon A) meets these criteria, based on the provided 510(k) summary (K100443).
1. Table of Acceptance Criteria and Reported Device Performance
The device's acceptance criteria are primarily established by its substantial equivalence to predicate devices, meaning its physical properties, intended use, and safety/effectiveness are comparable. The study did not define explicit numerical acceptance criteria for clinical performance but focused on demonstrating equivalence.
| Characteristic | Acceptance Criteria (Implied by Predicate Equivalence) | Reported Device Performance (Definitive, Flexlens - efrofilcon A) |
|---|---|---|
| Material | Silicone Hydrogel (efrofilcon A) | Same as predicate: efrofilcon A |
| Production Method | Lathe-Cut, custom manufactured | Same as predicate: Lathe-Cut, custom manufactured |
| Intended Use | Daily wear for correction of ametropia (myopia/hyperopia) in aphakic/non-aphakic persons with non-diseased eyes; also for irregular corneal conditions (keratoconus, post-graft fitting) | Same as predicate: Daily wear for correction of ametropia (myopia/hyperopia) in aphakic/non-aphakic persons with non-diseased eyes. Includes spherical, toric, multifocal, multifocal toric, and irregular cornea configurations. Indicated for management of irregular corneal conditions. |
| Functionality | Act as a refractive medium to focus light on the retina. | Same as predicate: Acts as a refractive medium that focus light rays from near and distant objects on the retina. |
| Water Content | 74% (matching "IntelliWave" and "ActiFresh 400" predicates) | 74% |
| Oxygen Permeability | Approx. 60 x 10^-11 (cm²/sec) (ml O₂/ml x hPa @ 35°C), (revised Fatt method) (matching "IntelliWave" predicate) | 59.8 x 10^-11 (cm²/sec) (ml O₂/ml x hPa @ 35°C), (revised Fatt method). (Stated as 60 x 10^-11 in comparative table) |
| Refractive Index | 1.38 | 1.38 |
| Light Transmission | Greater than 97% | Greater than 97% |
| Surface Character | Hydrophilic | Hydrophilic |
| Specific Gravity | 1.048 (hydrated) (Note: table shows 1.139 for both new device and IntelliWave - possible discrepancy or different measurement. Using 1.048 from description) | 1.048 (hydrated) |
| Biocompatibility | Non-toxic and non-irritating to ocular tissue. | Non-clinical toxicology and biocompatibility tests performed according to GLP regulations; results demonstrate packaging material and extracts are not toxic and not irritating. |
| Sterility | Sterile for the indicated shelf-life. | Non-clinical testing demonstrates lenses are sterile for the indicated shelf-life. |
| Shelf-Life Stability | Consistent product stability and packaging integrity for stated shelf-life. | Non-clinical testing validating product stability, package integrity, and sterilization process. |
| Clinical Performance | Clinical performance equivalent to predicate devices. | Clinical performance of the efrofilcon A lens material previously established (not required for this 510(k)). The device is identical to cleared "Intelliwave³ (efrofilcon A)" (K100221). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable for clinical testing of the current device. The document explicitly states: "The clinical performance of the (efrofilcon A) lens material has been previously established, and therefore was not required for this 510(k)." The current submission relies on the established performance of the material (efrofilcon A) which is part of the predicate device "Intelliwave³ (efrofilcon A)" (K100221).
- Data Provenance: Not specified for the historical clinical data related to the efrofilcon A material. However, all non-clinical toxicity and biocompatibility tests for the current device were conducted in accordance with GLP (Good Laboratory Practice) regulations, implying controlled laboratory settings rather than human subject testing in the context of this specific 510(k). The non-clinical data is prospective as it was specifically performed for this submission. The country of origin is not specified.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. No new clinical studies were conducted for this 510(k) submission, and therefore no "experts" were used to establish a ground truth for a test set in the context of a new clinical evaluation. The ground truth for safety and effectiveness is established by the previous clearance of the predicate device (Intelliwave³ efrofilcon A) and the inherent properties of the efrofilcon A material.
4. Adjudication Method for the Test Set
Not applicable. No new clinical test set requiring adjudication was used in this 510(k) submission.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This was not a diagnostic device involving a multi-reader multi-case (MRMC) study. The device is a contact lens, and its effectiveness is determined by its physical properties, biocompatibility, and functional equivalence to legally marketed predicate devices.
6. Standalone Performance Study
A standalone performance study for the clinical effectiveness of the algorithm (device) was not explicitly conducted as part of this 510(k) submission. The submission relies on the established clinical performance of the efrofilcon A lens material from prior clearances.
However, various non-clinical (in vitro and in vivo preclinical toxicology and biocompatibility) tests were performed on the Definitive, Flexlens device in a standalone manner to assess its safety. These tests assessed:
- Sterility
- Packaging material and extract toxicity/irritation
- Lens physical and material properties
7. Type of Ground Truth Used
The "ground truth" for the device's safety and effectiveness in this 510(k) is based on:
- Substantial Equivalence: The primary ground truth is the established safety and effectiveness of the predicate devices, particularly the "IntelliWave', Silicone Hydrogel Daily Wear Soft Contact Lens (efrofilcon A)" (K100221), to which the new device is stated to be identical in material and manufacturing process.
- Non-clinical Testing: Laboratory testing (toxicology, biocompatibility, sterility, shelf-life) performed according to GLP regulations and valid scientific protocols provided ground truth for these specific safety aspects.
- Previously Established Clinical Performance: The document states, "The clinical performance of the (efrofilcon A) lens material has been previously established," indicating reliance on prior clinical data for the material itself.
8. Sample Size for the Training Set
Not applicable. This device is a medical device (contact lens), not an AI/ML algorithm that requires a "training set" in the computational sense. The manufacturing process does not involve machine learning.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" for this type of device.
§ 886.5925 Soft (hydrophilic) contact lens.
(a)
Identification. A soft (hydrophilic) contact lens is a device intended to be worn directly against the cornea and adjacent limbal and scleral areas of the eye to correct vision conditions or act as a therapeutic bandage. The device is made of various polymer materials the main polymer molecules of which absorb or attract a certain volume (percentage) of water.(b)
Classification. (1) Class II if the device is intended for daily wear only.(2) Class III if the device is intended for extended wear.
(c)
Date PMA or notice of completion of a PDP is required. As of May 28, 1976, an approval under section 515 of the act is required before a device described in paragraph (b)(2) of this section may be commercially distributed. See § 886.3.